Levomil: Prophylactic Use of Levosimendan Versus Milrinone in Open Heart Surgery in Infants

Sponsor

Ludwig Boltzmann Gesellschaft (Other)

Overall Status

Unknown status

CT.gov ID

NCT00549107

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

Pediatric patients, especially infants undergoing open heart surgery have a predictable fall in cardiac index 6 to 18 hours after surgery, the so-called low cardiac output syndrome (LCOS). Patients, who have LCOS require more monitoring, more medication and a longer stay in intensive care unit. To prevent LCOS the phosphodiesterase inhibitor milrinone is routinely used during the first 24 hours after surgery. Levosimendan, a calcium- sensitizer improves cardiac muscle contractile force, vascular smooth muscle relaxation and coronary blood flow through calcium sensitization of the myocardial contractile filaments and opening of potassium channels without increasing oxygen consumption of the heart muscle cells. As the myocardium of infants is more calcium dependent than in later life, levosimendan should be of special benefit in this age group. The purpose of this study is to investigate whether levosimendan is superior to milrinone in preventing LCOS in infants after corrective open heart surgery.

Condition or Disease	Intervention/Treatment	Phase
Low Cardiac Output Syndrome	Drug: Levosimendan Drug: Milrinone	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Phase 2 Prospective, Randomized, Double-Blind Pilot Study on Cardiac Output Following Corrective Open Heart Surgery in Children Less Than One Year: Use of Levosimendan Versus Milrinone.

Study Start Date :

Sep 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Levosimendan
Active Comparator: 2	Drug: Milrinone

Arm

Intervention/Treatment

Experimental: 1

Drug: Levosimendan

Active Comparator: 2

Drug: Milrinone

Outcome Measures

Primary Outcome Measures

Cardiac output measured by a transesophageal probe [48 hours]

Secondary Outcome Measures

Changes in mixed venous saturation [48 hours]
Serum lactate levels [48 hours]
Cardiac output and ventricular function assessed by echocardiography [48 hours]
Mean arterial, left atrial and central venous pressure [48 hours]
Need of catecholamines assessed with the inotropic score [48 hours]
Urine output [48 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 12 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age younger than one year
corrective open heart surgery with biventricular repair, except tetralogy of fallot

Exclusion Criteria:

Missing written consent of parents
Weight less than 3 kg
preoperative LCOS
gestational age less than 36 weeks
preexisting renal failure
preexisting thrombopenia
preoperative cardiopulmonary resuscitation
preoperative use of milrinone or levosimendan

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children´s Heart Center Linz	Linz		Austria	4020

Sponsors and Collaborators

Ludwig Boltzmann Gesellschaft

Investigators

Principal Investigator: Evelyn Lechner, MD, Children´s Heart Center Linz
Study Director: Hans Gombotz, MD, PHD, General Hospital Linz, Ludwig Boltzmann Gesellschaft
Principal Investigator: Anna Hofer, MD, General Hospital Linz
Study Chair: Gerald Tulzer, MD, PHD, Children´s Heart Center Linz